Changes in Tissue and Cerebral Oxygenation Following Spinal Anesthesia in Neonates, Infants, and Children

Not Applicable

Completed

• Conditions: Infants Undergoing Surgery
• Interventions: Device: NIRS

• Registration Number: NCT02840253
• Lead Sponsor: Joseph D. Tobias

Brief Summary

Investigators have started an awake spinal anesthesia program in conjunction with pediatric surgical colleagues. Patients are offered the option of awake spinal anesthesia instead of general anesthesia for appropriate surgical procedures. Previous studies have demonstrated a lack of significant hemodynamic changes in neonates and infants following spinal anesthesia; however, there are limited data regarding its impact on tissue oxygenation. The goal of the current study is to assess changes in tissue and cerebral oxygenation using non-invasive near infrared spectroscopy following spinal anesthesia.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2016-06-23
• Study Start: 2016-07
• Study First Submitted QC: 2016-07-18
• Study First Posted: 2016-07-21
• Primary Completion: 2017-05-12
• Study Completion: 2017-05-12
• Results First Submitted: 2018-06-05
• Status Verified: 2018-08
• Results First Submitted QC: 2018-08-15
• Last Update Submitted: 2018-08-15
• Results First Posted: 2018-08-16
• Last Update Posted: 2018-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 23

Inclusion Criteria

• All patients that are candidates for and have agreed to spinal anesthesia.

Exclusion Criteria

• none

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
NIRS	NIRS	Non-invasive near infrared spectroscopy to assess changes in tissue and cerebral oxygenation.

Primary Outcome Measures

Name	Time	Method
Cerebral Non-invasive Near Infrared Spectroscopy (NIRS)	Intraoperative measure	Change in cerebral oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).
Tissue Non-invasive Near Infrared Spectroscopy (NIRS)	Intraoperative measure	Change in tissue oxygen saturation from immediately after spinal anesthesia placement to conclusion of monitoring (30 mins post block).